Objectives. A short study was undertaken to assess the acceptability and sh
ort-term safety of a vaginal microbicide (COL-1492) and its compatibility w
ith the preference for dry sex among sex workers at truck stops in KwaZulu-
Natal.
Design. A randomised double-blind placebo-controlled trial was conducted fr
om March to July 1996.
Setting. Truckstops in KwaZulu-Natal, South Africa.
Participants. Twenty sex workers. The participants were assigned to either
COL-1492 (which contains 52.5 mg of nonoxynol 9) or a placebo. The first mo
nth of use was followed by a 1-month washout period; thereafter the women w
ho had used the COL-1492 used the placebo land vice versa) during the third
month. Baseline and fortnightly assessment included microbiology and serol
ogy for sexually transmitted diseases, questionnaires to assess acceptabili
ty of COL-1492, and a clinical examination by colposcopy.
Outcome measures. Acceptability of the product/placebo and short-term safet
y of the product.
Results and conclusion. Our study revealed that while on COL-1492, 19 of th
e 20 women found the product to be entirely satisfactory. On colposcopy, si
milar lesions were found in the women who were using COL-1492 and those usi
ng placebo. This study has shown that COL-1492 was found to be acceptable b
y sex workers. COL-1492 was not associated with more colposcopic changes in
the vagina and cervix compared with placebo. It was concluded that conditi
ons are conducive within this cohort of sex workers for a COL-1492 efficacy
trial.